Digestive System NeoplasmsPhase 2NCT07196540

IP rmhTNF-NC + Tislelizumab + Palliat RT for GIT Tumor Malignant Ascites After Failed Std Tx

A Phase 2 study testing Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumab in people with Digestive System Neoplasms, run by Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

This study is a prospective, non-randomized, dual-cohort Phase II clinical trial designed to explore the efficacy and safety of radiotherapy combined with intraperitoneal injection of Recombinant Mutant Human Tumor Necrosis Factor (rmhTNF-NC) and tislelizumab in the treatment of malignant ascites that has failed prior… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Digestive System Neoplasms
What is being tested?: Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: No sites listed yet
Study dates: 26 Sep 2025to 31 Dec 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age ≥ 18 years, regardless of gender. 2. Histologically or cytologically confirmed malignant ascites originating from digestive system tumors (confirmed by ascites cytology as malignant or clinically diagnosed as peritoneal metastases based on imaging and symptoms).
3. Presence of large-volume peritoneal metastatic lesions with radiotherapy indications as assessed by a Multidisciplinary Team (MDT) (Cohort A), including an abdominal mass with the longest diameter ≥ 5 cm, or masses invading structures such as the abdominal wall or intra-abdominal muscles causing symptoms like pain.
4. Moderate or greater amount of ascites, either (first-time treatment) or refractory to previous intraperitoneal therapy with conventional chemotherapeutic agents and/or biological response modifiers. Moderate ascites is defined as: ① Ascites depth ≥ 3 cm on supine ultrasound; ② Accompanied by clinical symptoms (such as chest tightness, shortness of breath, abdominal distension, and discomfort judged by the investigator to be related to ascites).
5. ECOG performance status of 0-2. 6. Expected survival time > 3 months. 7. Essentially normal cardiac and pulmonary function. 8. Adequate organ function, as evidenced by the following laboratory parameters:
Peripheral blood count: WBC ≥ 4.0 × 10⁹/L, PLT ≥ 80 × 10⁹/L, Hb ≥ 90 g/L.
Renal function: Serum creatinine ≤ 2 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 ml/min.

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Liver function: Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); or Total bilirubin > ULN but with direct bilirubin ≤ ULN; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (ALT or AST ≤ 5 × ULN allowed for patients with liver metastases).
Adequate coagulation function, defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN.
9. Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels and clinical manifestations should be evaluated; patients can be enrolled if comprehensively assessed and not in an acute active phase.
10. For non-surgically sterilized or premenopausal female patients, use of a medically approved contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) is required during the study treatment period and for 6 months after the end of study treatment; Non-surgically sterilized premenopausal female patients must have a negative serum or urine HCG test within 7 days prior to study enrollment; must be non-lactating; For male patients with partners of childbearing potential, effective contraception should be used during the trial and for 6 months after the last dose of the study drug.
11. Voluntary participation in this study with good compliance, provision of written informed consent, and ability to cooperate with follow-up observations.

Who cannot join

1. History of allergy to original tumor necrosis factor (TNF), its derivatives, or tislelizumab.
2. Diagnosis of malignancies other than digestive tract tumor within 5 years prior to the first dose (excluding radically cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection).
3. Previous use of tumor necrosis factor (TNF) or its derivative drugs. 4. Significant tumor burden in other organs, and the investigator believes that enrollment in this study would be detrimental to the patient's disease control.
5. Treatment with any other investigational drugs within 7 days prior to the first dose, or participation in another interventional clinical trial; or receipt of anti-tumor drug therapy (including Chinese herbal medicine with anti-tumor indications) within 7 days before the first dose of the study drug.
6. Pregnant or breastfeeding women; women of childbearing potential unwilling to use contraception during the study period; or men unwilling to use effective contraception during treatment and for 1 year thereafter.
7. Significant impairment of vital organ function. 8. Patients with obvious bleeding tendency. 9. Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to the first dose, New York Heart Association (NYHA) Class III/IV congestive heart failure, and uncontrolled arrhythmias (subjects with a pacemaker or atrial fibrillation with well-controlled heart rate are allowed).

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10. Presence of ECG changes or history considered clinically significant by the investigator; QTcF interval > 480 ms during screening. For subjects with intraventricular conduction block (QRS interval > 120 ms), JTc interval may be used instead of QTc interval (if JTc is used instead of QTc, JTc must be ≤ 340 ms).
11. Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after optimal medical therapy), history of hypertensive crisis or hypertensive encephalopathy.
12. Presence of severe acute infection that is uncontrolled; current fever (> 38°C), or presence of purulent and chronic infections, or non-healing wounds.
13. Patients with radiologically confirmed encapsulated ascites; diagnosed abdominal infection.
14. Acute or chronic active hepatitis B or C infection: Hepatitis B virus (HBV) DNA > 2000 IU/mL or 10⁴ copies/mL; Hepatitis C virus (HCV) RNA > 10³ copies/mL; co-infection with Hepatitis B surface antigen (HBsAg) and anti-HCV antibody positivity. Subjects can be enrolled if levels are below these criteria after nucleotide antiviral therapy; known history of human immunodeficiency virus (HIV) infection or positive HIV test.
15. History or evidence of significant bleeding tendency within 3 months prior to enrollment (bleeding > 30 mL, hematemesis, melena, hematochezia within 3 months), hemoptysis (> 5 mL of fresh blood within 4 weeks); history of hereditary or acquired bleeding disorders or coagulation dysfunction; history of clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; history of arterial or venous thrombotic diseases within 6 weeks prior to enrollment.
16. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
17. Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or anticipation of the need for major surgery during the study treatment period.
18. Inadequate recovery from toxicity and/or complications from previous interventions or major surgery prior to initiation of treatment.
19. Pregnant or lactating women, or subjects who plan to conceive or father children during the study period from screening until the completion of the safety follow-up visit (90 days after the last dose for male subjects).
20. Radiotherapy within 4 weeks prior to the first dose of the study drug. All radiation-related toxicities must have been resolved, must not require corticosteroids, and must exclude radiation pneumonitis, radiation enteritis, etc. A 2-week washout period is permitted for palliative radiotherapy for non-CNS diseases.
21. Uncontrolled neurological or psychiatric disorders, or mental disabilities that lead to poor compliance and inability to cooperate or describe treatment response; uncontrolled primary brain tumors or central nervous system metastases with significant symptoms of intracranial hypertension or neuropsychiatric symptoms.
22. Any other condition deemed by the investigator as inappropriate for participation in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dongsheng Zhang, Ph.D. contact

13719437860

zhangdsh@sysucc.org.cn

About this study

Official title: A Prospective, Non-Randomized, Two-Cohort Clinical Study of Intraperitoneal Injection of Recombinant Modified Human Tumor Necrosis Factor Combined With Tislelizumab and Palliative Radiotherapy in the Treatment of Malignant Ascites From Digestive Tract Tumors After Failure of Previous Standard Treatments

After completing the informed consent process, eligible patients who meet the inclusion criteria will be enrolled. Participants will receive palliative radiotherapy combined with intraperitoneal perfusion of rmhTNF-NC and tislelizumab according to the study protocol. Before and after one cycle of treatment, abdominal ultrasound will be used to evaluate the response rate of ascites. Safety assessments will be conducted using NCI-CTCAE v5.0.

Read the detailed description

This study is a prospective, dual-cohort clinical trial following a Simon two-stage design. Eligible subjects who met the inclusion criteria were enrolled. All participants were assigned to the following cohorts, consisting of patients with malignant ascites of the gastrointestinal tract confirmed by cytology or histology, who had experienced failure of prior standard therapy and required clinical intervention due to symptomatic disease. After providing signed informed consent and completing screening procedures, the patients received the following treatments:

Cohort A (patients with large-volume abdominal metastatic lesions):

Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab)

Cohort B (patients without measurable abdominal metastatic lesions):

Whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab) All patients received only one treatment cycle. Objective efficacy was evaluated 4 weeks after treatment completion according to WHO criteria. Safety was assessed using NCI-CTCAE version 5.0. Subsequent treatments were not restricted by the study protocol, and clinicians could adjust the treatment plan based on the patient's specific condition.

Conditions: Digestive System Neoplasms
Being tested: Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumab
Medical subject headings: Digestive System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumabCombination product
radiotherapy + rmhTNF-NC + tislelizumab

Study groups in NCT07196540
Study group	Role	What they receive
Cohort A (patients with large-volume abdominal metastatic lesions)	Experimental	Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab) Radiotherapy for large-volume abdominal lesions（5-8Gy×5F, D1-D5） whole peritoneal cavity low-dose radiotherapy （1.5Gy×5F, D1-D5） rmhTNF-NC（300IU，ip，D1、D4、 D7、D10） tislelizumab（100mg，ip，D1、D15） Receives: Combination Product: Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumab
Cohort B (patients without measurable abdominal metastatic lesions)	Experimental	Whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab) whole peritoneal cavity low-dose radiotherapy （1.5Gy×5F, D1-D5） rmhTNF-NC（300IU，ip，D1、D4、 D7、D10） tislelizumab（100mg，ip，D1、D15） Receives: Combination Product: Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR
Objective Response Rate (ORR) for Ascites (defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR) according to WHO criteria).
Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 202531 Dec 2029

First posted29 Sep 2025
Study start26 Sep 2025 (estimated)
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Digestive System NeoplasmsStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 78 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07196540
Sponsor's protocol ID: B2024-595-01
Status last verified: Sep 2025
First submitted: 15 Sep 2025
Last updated: 29 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Dongsheng Zhang, Ph.D.

13719437860

zhangdsh@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Digestive System Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Non-Randomized, Two-Cohort Clinical Study of Intraperitoneal Injection of Recombinant Modified Human Tumor Necrosis Factor Combined With Tislelizumab and Palliative Radiotherapy in the Treatment of Malignant Ascites From Digestive Tract Tumors After Failure of Previous Standard Treatments
ClinicalTrials.gov ID: NCT07196540
Acronym / sponsor ID: B2024-595-01
Conditions: Digestive System Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 78 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 26 Sep 2025 (estimated)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 29 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Cohort A (patients with large-volume abdominal metastatic lesions):

Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab)

Cohort B (patients without measurable abdominal metastatic lesions):

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A (patients with large-volume abdominal metastatic lesions)	Experimental	Combination Product: Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumabRadiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab) Radiotherapy for large-volume abdominal lesions（5-8Gy×5F, D1-D5） whole peritoneal cavity low-dose radiotherapy （1.5Gy×5F, D1-D5） rmhTNF-NC（300IU，ip，D1、D4、 D7、D10） tislelizumab（100mg，ip，D1、D15）
Cohort B (patients without measurable abdominal metastatic lesions)	Experimental	Combination Product: Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumabWhole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab) whole peritoneal cavity low-dose radiotherapy （1.5Gy×5F, D1-D5） rmhTNF-NC（300IU，ip，D1、D4、 D7、D10） tislelizumab（100mg，ip，D1、D15）

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

1. Age ≥ 18 years, regardless of gender. 2. Histologically or cytologically confirmed malignant ascites originating from digestive system tumors (confirmed by ascites cytology as malignant or clinically diagnosed as peritoneal metastases based on imaging and symptoms).
3. Presence of large-volume peritoneal metastatic lesions with radiotherapy indications as assessed by a Multidisciplinary Team (MDT) (Cohort A), including an abdominal mass with the longest diameter ≥ 5 cm, or masses invading structures such as the abdominal wall or intra-abdominal muscles causing symptoms like pain.
4. Moderate or greater amount of ascites, either (first-time treatment) or refractory to previous intraperitoneal therapy with conventional chemotherapeutic agents and/or biological response modifiers. Moderate ascites is defined as: ① Ascites depth ≥ 3 cm on supine ultrasound; ② Accompanied by clinical symptoms (such as chest tightness, shortness of breath, abdominal distension, and discomfort judged by the investigator to be related to ascites).
5. ECOG performance status of 0-2. 6. Expected survival time > 3 months. 7. Essentially normal cardiac and pulmonary function. 8. Adequate organ function, as evidenced by the following laboratory parameters:
9. Thyroid Stimulating Hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels and clinical manifestations should be evaluated; patients can be enrolled if comprehensively assessed and not in an acute active phase.

Key exclusion criteria (19 listed)

1. History of allergy to original tumor necrosis factor (TNF), its derivatives, or tislelizumab.
2. Diagnosis of malignancies other than digestive tract tumor within 5 years prior to the first dose (excluding radically cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection).
3. Previous use of tumor necrosis factor (TNF) or its derivative drugs. 4. Significant tumor burden in other organs, and the investigator believes that enrollment in this study would be detrimental to the patient's disease control.
5. Treatment with any other investigational drugs within 7 days prior to the first dose, or participation in another interventional clinical trial; or receipt of anti-tumor drug therapy (including Chinese herbal medicine with anti-tumor indications) within 7 days before the first dose of the study drug.
6. Pregnant or breastfeeding women; women of childbearing potential unwilling to use contraception during the study period; or men unwilling to use effective contraception during treatment and for 1 year thereafter.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumabradiotherapy + rmhTNF-NC + tislelizumab	Combination product	Cohort A (patients with large-volume abdominal metastatic lesions), Cohort B (patients without measurable abdominal metastatic lesions)

Primary outcome

ORR
Time frame: Up to 4 weeks
Objective Response Rate (ORR) for Ascites (defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR) according to WHO criteria).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Digestive System Neoplasms

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Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Dongsheng Zhang, Ph.D. contact

13719437860

zhangdsh@sysucc.org.cn

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dongsheng Zhang, Ph.D. (13719437860, zhangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07196540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.